UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the care prevention intervention method that increased a new comprehensive index for sarcopenia assessment
Title of the study (Brief title)	ADL intervention study
Region	Japan

Condition
Condition	Local elderly people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For elderly people resident in an area, we conduct ADL movement instruction and perform the effect inspection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Knee VAS, JKOM, 5m walking speed, grip, patellar inferior mobility, Knee joint flexure excursion, Knee joint extension excursion, Ely' s test, muscular strength (knee extension, hip joint extension, hip joint abduction), SF-8, body composition.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	intervention 1 draw-in gait 2 Hip joint dominant ADL 3 Japanese sitting Three months enforcement. We record the number of times.
Interventions/Control_2	control 1 SLR ex, Ten times of 3 set 2 Knee automatic flexural excursion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Elderly people resident in an area
Key exclusion criteria	1 Dementia 2 Painful bone and joint disease 3 Cerebrovascular person with a disability
Target sample size	50

Research contact person
Name of lead principal investigator	Susumu Ota
Organization	Department of Rehabilitation and Care, Seijoh, University.
Division name	Physical therapy
Address	2-172 Fukinodai, Tokai, Aichi, 476-8588, Japan.
TEL	052-601-6245
Email	ohko-h@seijoh-u.ac.jp

Public contact
Name of contact person	Hiroshi Ohko
Organization	Department of Rehabilitation and Care, Seijoh, University.
Division name	Physical therapy
Address	2-172 Fukinodai, Tokai, Aichi, 476-8588, Japan.
TEL	052-601-6245
Homepage URL
Email	ohko-h@seijoh-u.ac.jp

Sponsor
Institute	Department of Rehabilitation and Care, Seijoh, University.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Rehabilitation and Care, Seijoh, University.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2016 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026539